Production Technician I - Weekend Day
- Indianapolis, IN
- $52,400-97,400 per year
- Permanent
- Full-time
- Executes all activities related to the manufacturing of RLT products. Responsibilities include operating and maintaining grade A isolators, focusing on KPI goals as well as ensuring all state, federal and Novartis radiation safety guidelines are adhered to.
- Responsible for successful on-time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
- Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators. Conducts routine and dynamic environmental monitoring as required.
- Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
- Ensures all cGMP compliance activities are followed.
- Participation in assigned qualification/validation activities, and assist on deviation investigations and inspections, as necessary.
- Prepares applicable documents and records such as batch records, shipping documents, and training materials.
- Bachelor’s degree in relevant Engineering or Scientific discipline is highly preferred; If the applicant does not have a degree, a minimum of 1+ year’ of experience in cGMP or aseptic environment is required.
- Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing is highly preferred.
- Ability to gown aseptically and work in a clean room environment (Grade C) area for extended periods of time is required.
- Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.
- Ability to lift or carry up to 35 pounds
- Radio Pharma experience preferred.
- English.